FDA 510(k)

DORA Disposable A.V. Fistula Needle Sets

K-번호: K163025 · 2017-07-20

신청자Bain Medical Equipment (Guangzhou) Co., Ltd.

결정일2017-07-20

제품 코드FIE

자문 위원회GU

결정Substantially Equivalent

기기 요약

DORA Disposable A.V. Fistula Needle Sets is the device name listed in this FDA 510(k) record. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2017-07-20 under 510(k) number K163025. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the DORA Disposable A.V. Fistula Needle Sets?

DORA Disposable A.V. Fistula Needle Sets is a medical device that received FDA 510(k) clearance on 2017-07-20. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K163025.

When did DORA Disposable A.V. Fistula Needle Sets receive FDA 510(k) clearance?

DORA Disposable A.V. Fistula Needle Sets received FDA 510(k) clearance on 2017-07-20, under 510(k) number K163025.

Who is the listed applicant for DORA Disposable A.V. Fistula Needle Sets?

The FDA 510(k) record lists Bain Medical Equipment (Guangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DORA Disposable A.V. Fistula Needle Sets?

The FDA product code for DORA Disposable A.V. Fistula Needle Sets is FIE.

Bain Medical Equipment (Guangzhou) Co., Ltd.를 신청인으로 등재한 기타 기록

K252423NovaLine Tubing Set for Hemodialysis (BL 124)K240164NovaLine SP-C35 Transducer Protector (956007)K213015DORA Disposable A.V. Fistula Needle Sets K201866NovaLine Tubing Sets for Hemodialysis K203524Surgical Masks K161582DORA Tubing Sets for Hemodialysis

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